Icosapent Ethyl recalls

The FDA has published 3 recalls involving Icosapent Ethyl since 2025. The latest was reported on 18 Mar 2026. Most were for packaging defects. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2025

Last 12 months2reported

Class I00% of total

Ongoing2latest 18 Mar 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 1 0 0Aug 0 0 0Nov 0 1 0Feb 1 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why icosapent ethyl is recalled

Companies

Zydus Pharmaceuticals3100%

By year

2026267%
2025133%

Ongoing icosapent ethyl recalls

2 active

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Drug	CLASS II	Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl	Zydus Pharmaceuticals	Other	Nationwide
28 Jan 2026Drug	CLASS II	Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA)	Zydus Pharmaceuticals	Potency & Assay	Nationwide

All icosapent ethyl recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Drug	CLASS II	Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl	Zydus Pharmaceuticals	Other	Nationwide
28 Jan 2026Drug	CLASS II	Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA)	Zydus Pharmaceuticals	Potency & Assay	Nationwide
18 Jun 2025Drug	CLASS II	Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl	Zydus Pharmaceuticals	Packaging Defects	IL, MS, PA

Should you stop taking Icosapent Ethyl?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.